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Open-Label, Bridging Study of Telaprevir in Treatment-Naïve and Treatment-Experienced Russian Patients With Genotype 1 Chronic Hepatitis C

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ClinicalTrials.gov Identifier: NCT01498068
Recruitment Status : Completed
First Posted : December 23, 2011
Results First Posted : December 30, 2013
Last Update Posted : January 30, 2015
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag International NV

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Genotype 1 Chronic Hepatitis C
Interventions Drug: Telaprevir
Drug: Pegylated-interferon-alfa-2a
Drug: Ribavirin
Enrollment 36
Recruitment Details The study was conducted at 5 sites in Russia.
Pre-assignment Details Of the 39 participants screened, 36 participants (16 treatment-naïve/ 20 treatment-experienced) were enrolled and treated.
Arm/Group Title Treatment-naïve Treatment-experienced
Hide Arm/Group Description Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study. Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
Period Title: Overall Study
Started 16 20
Completed 15 19
Not Completed 1 1
Reason Not Completed
Withdrawal by Subject             1             1
Arm/Group Title Treatment-naïve Treatment-experienced Total
Hide Arm/Group Description Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study. Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study. Total of all reporting groups
Overall Number of Baseline Participants 16 20 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16 participants 20 participants 36 participants
<= 45 years 13 12 25
Between 45 and 65 years 2 8 10
> 65 years 1 0 1
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 20 participants 36 participants
Female
9
  56.3%
13
  65.0%
22
  61.1%
Male
7
  43.8%
7
  35.0%
14
  38.9%
1.Primary Outcome
Title Number of Participants With Extended Rapid Virologic Response (eRVR)
Hide Description A eRVR is defined as having hepatitis C virus (HCV) ribonucleic acid (RNA) less than 25 IU/mL, (target not detected) at Weeks 4 and 12 of treatment.
Time Frame Week 4 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis (FA) population: All participants who received at least one dose of the study medication.
Arm/Group Title Treatment-naïve Treatment-experienced
Hide Arm/Group Description:
Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
Overall Number of Participants Analyzed 16 20
Measure Type: Number
Unit of Measure: Participants
13 18
2.Secondary Outcome
Title Median Change in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
Hide Description Changes from baseline in log10 HCV RNA levels were calculated.
Time Frame Baseline (Week 0), Week 4, Week 8, Week 12, Week 24, Week 32, Week 40, and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis (FA) population: All participants who received at least one dose of the study medication. "n" signifies number of participants who were evaluable at each specified timepoint for each arm, respectively.
Arm/Group Title Treatment-naïve Treatment-experienced
Hide Arm/Group Description:
Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
Overall Number of Participants Analyzed 16 20
Median (Full Range)
Unit of Measure: Log 10 IU/mL
Baseline (n=16, 20)
6.20
(4.6 to 6.9)
6.10
(5.7 to 7.0)
Week 4 (n=16, 20)
-5.47
(-6.2 to -3.9)
-5.33
(-6.3 to -3.5)
Week 8 (n=16,19)
-5.50
(-6.2 to -3.9)
-5.39
(-6.3 to -5.00)
Week 12 (n=15,19)
-5.46
(-6.2 to -3.9)
-5.39
(-6.3 to -5.00)
Week 24 (n=14, 19)
-5.53
(-6.2 to -3.9)
-5.39
(-6.3 to -0.6)
Week 32 (n=2, 12)
-5.30
(-5.5 to -5.1)
-5.46
(-6.3 to -5.2)
Week 40 (n=2, 12)
-5.30
(-5.5 to -5.1)
-5.46
(-6.3 to -5.2)
Week 48 (n=2, 12)
-3.14
(-5.1 to -1.2)
-5.46
(-6.3 to -5.2)
3.Secondary Outcome
Title Number of Participants With Rapid Virologic Response (RVR) at Week 4
Hide Description A RVR is defined as having hepatitis C virus (HCV) ribonucleic acid (RNA) less than 25 IU/mL, (target not detected) at Week 4
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis (FA) population: All participants who received at least one dose of the study medication.
Arm/Group Title Treatment-naïve Treatment-experienced
Hide Arm/Group Description:
Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
Overall Number of Participants Analyzed 16 20
Measure Type: Number
Unit of Measure: Participants
14 18
4.Secondary Outcome
Title Number of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Less Than 25 IU/mL, (Target Not Detected) at Weeks 8, 12, 24, 32, 40 and 48
Hide Description The table below shows number of participants with HCV RNA Less than 25 IU/mL, (target not detected) at Weeks 8, 12, 24, 32, 40 and 48. Only 3 treatment-naive and 14 Treatment-experienced participants were assigned to receive study treatment after Week 24. Only participants still receiving Treatment were assessed at 32, 40, and 48 weeks.
Time Frame Weeks 8, 12, 24, 32, 40 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis (FA) population: All participants who received at least one dose of the study medication. "n" signifies number of participants who were evaluable at each specified timepoint for each arm, respectively.
Arm/Group Title Treatment-naïve Treatment-experienced
Hide Arm/Group Description:
Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
Overall Number of Participants Analyzed 16 20
Measure Type: Number
Unit of Measure: Participants
Week 8 (n=16, 20) 16 19
Week 12 (n=16, 20) 15 19
Week 24 (n=16, 20) 15 18
Week 32 (n=3, 14) 2 12
Week 40 (n=3, 14) 2 12
Week 48 (n=3, 14) 1 12
5.Secondary Outcome
Title Number of Participants With Virologic Failure
Hide Description Virologic failure is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels more than 1,000 IU/mL at Weeks 4, 8, 12, 24, 32, or 40.
Time Frame Week 4, Week 8, Week 12, Week 24, Week 32, or Week 40
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis (FA) population: All participants who received at least one dose of the study medication.
Arm/Group Title Treatment-naïve Treatment-experienced
Hide Arm/Group Description:
Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
Overall Number of Participants Analyzed 16 20
Measure Type: Number
Unit of Measure: Participants
1 2
6.Secondary Outcome
Title Number of Participants in Each Specific Category of Treatment Outcome
Hide Description Participants were evaluated for following 4 categories of treatment outcome;Sustained Virologic Response 12 Weeks After Last Planned Dose of Study Medication(SVR12):hepatitis C virus (HCV)ribonucleic acid (RNA)<25 IU/mL(target not detected)12 weeks after last planned dose of study medication;Relapse:HCV RNA =>25 IU/mL during follow-up period after previous HCV RNA<25 IU/mL at planned end of treatment(EOT)[Week 24 or Week 48] and participant did not achieve SVR12planned;On treatment virologic failure:meeting virologic stopping rule and/or having detectable HCV RNA at EOT with viral breakthrough(having a confirmed increase >1 log 10 in HCV RNA level from the lowest level reached or confirmed value of HCV RNA >100 IU/mL in participants whose HCV RNA has previously become <25 IU/mL during treatment).Stopping rule defined as HCV RNA value >1000 IU/mL at Week 4, 8 or 12 or detectable HCV RNA at Week 24, 32 or 40;Other:HCV RNA <25 IU/mL at actual EOT and never HCV RNA =>25 IU/mL thereafter.
Time Frame From Day 1 (Baseline) up to Follow-up visit (Week 36 or Week 60)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis (FA) population: All participants who received at least one dose of the study medication.
Arm/Group Title Treatment-naïve Treatment-experienced
Hide Arm/Group Description:
Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
Overall Number of Participants Analyzed 16 20
Measure Type: Number
Unit of Measure: Participants
SVR12 14 16
Relapse 0 1
On treatment virologic failure 1 2
Other 1 1
Time Frame 60 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment-naïve Treatment-experienced
Hide Arm/Group Description Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study. Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
All-Cause Mortality
Treatment-naïve Treatment-experienced
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment-naïve Treatment-experienced
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Treatment-naïve Treatment-experienced
Affected / at Risk (%) Affected / at Risk (%)
Total   16/16 (100.00%)   19/20 (95.00%) 
Blood and lymphatic system disorders     
Anaemia  1  6/16 (37.50%)  6/20 (30.00%) 
Neutropenia  1  2/16 (12.50%)  4/20 (20.00%) 
Thrombocytopenia  1  2/16 (12.50%)  1/20 (5.00%) 
Gastrointestinal disorders     
Nausea  1  1/16 (6.25%)  2/20 (10.00%) 
Anal pruritus  1  0/16 (0.00%)  2/20 (10.00%) 
General disorders     
Influenza like illness  1  6/16 (37.50%)  9/20 (45.00%) 
Pyrexia  1  6/16 (37.50%)  3/20 (15.00%) 
Injection site erythema  1  1/16 (6.25%)  1/20 (5.00%) 
Asthenia  1  5/16 (31.25%)  3/20 (15.00%) 
Investigations     
Alanine aminotransferase increased  1  2/16 (12.50%)  2/20 (10.00%) 
Aspartate aminotransferase increased  1  1/16 (6.25%)  1/20 (5.00%) 
Blood uric acid increased  1  2/16 (12.50%)  0/20 (0.00%) 
Gamma-glutamyltransferase increased  1  1/16 (6.25%)  1/20 (5.00%) 
Haemoglobin decreased  1  0/16 (0.00%)  2/20 (10.00%) 
Psychiatric disorders     
Insomnia  1  0/16 (0.00%)  2/20 (10.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  3/16 (18.75%)  0/20 (0.00%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  4/16 (25.00%)  2/20 (10.00%) 
Rash  1  4/16 (25.00%)  0/20 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 14.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Compound Development Team Leader
Organization: Janssen Belgium
Phone: 32 14 64 13 70
Layout table for additonal information
Responsible Party: Janssen-Cilag International NV
ClinicalTrials.gov Identifier: NCT01498068     History of Changes
Other Study ID Numbers: CR100676
VX-950HPC3007 ( Other Identifier: Janssen-Cilag International NV, Belgium )
First Submitted: December 6, 2011
First Posted: December 23, 2011
Results First Submitted: September 11, 2013
Results First Posted: December 30, 2013
Last Update Posted: January 30, 2015